S.F.-P.A.P. TEST COUNTER IMMUNOELECTRO— 510(k) K792059

Name: FDA 510(k) clearance K792059
Creator: U.S. Food and Drug Administration
Published: 1979-12-13

Substantially Equivalent

S.F. Biologicals, Inc.

FDA 510(k) clearance K792059 for S.F.-P.A.P. TEST COUNTER IMMUNOELECTRO, Substantially Equivalent on 1979-12-13. Applicant: S.F. Biologicals, Inc.. Device class: 2.

Clearance details

Applicant: S.F. Biologicals, Inc.
Product code: Product code JFH
Device class: Class 2
Regulation: 21 CFR 862.1020
Advisory panel: Clinical Chemistry
Date received: 1979-10-15
Decision date: 1979-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JFH

view all

K000257 — IMMULITE 2000 PAP, MODELS L2KPA2, L2KPA62000-02-23
K981573 — UBI MAGIWEL PAP (PROSTATIC ACID PHOSPHATASE) EIA QUANTITATVE1998-09-15
K964756 — PROSTATIC ACID PHOSPHATASE REAGENT TEST/PROSTATIC ACID PHOSPHATASE REAGENT KIT1997-04-23
K931701 — IMMULITE PAP1994-01-27
K925377 — IMX PAP1993-01-13

Data sourced from openFDA. This site is unofficial and independent of the FDA.